NCT04162444 Results of the Aortic Valve Reconstruction in Children

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 40 participants in total. It began in 2020-02-18 with a primary completion date of 2026-10.

Brief Summary

Aortic valve disease counts up to 5% of cases of congenital heart disease being one of the most common congenital malformations of the cardiovascular system. This disease requires replacement of the damaged valve which in itself is not a trivial task to complete in children as there is still no available best practice for valve replacement. Today, the following alternative variants are performed in children: mechanical aortic prosthesis, xenografts, allografts, and pulmonary autograft (Ross procedure) and each has its potential advantages and disadvantages. Mechanical aortic prostheses require lifelong anticoagulation therapy and repeated surgeries to replace mechanical valves during child growth. Available xenografts in children also has suboptimal results not only because of absence of growth potential, but also due to development of degenerative changes in biological tissue of the graft leaflets. Allograft tissues are exposed to rapid biodegradation in the recipient body and thus requiring repeated surgeries associated with higher difficulty, high risk of hemorrhages, and injury of the coronary injuries. Ross procedure was proposed as theoretically the most evidence-based reconstruction of the aortic valve in children. Even successfully performed Ross operation transforms one-valve disorder into two-valve disease. The accumulation of knowledge on the anatomy of the aortic root and improvement of surgical techniques led to the development of new methods for reconstruction of the valve function. The technique is widely applied in adult cardiac surgery, uses glutaraldehyde-treated autopericardium for augmentation of the leaflets. Absence of foreign material provides no need for anticoagulation therapy. Potentially, reconstruction of the aortic valve with autopericardium can be widely used in children. Aim is to study safety, clinical and hemodynamic efficacy of the method of the aortic valve reconstruction with autopericardium in children with aortic valve disease. Patients aged 29 days to 12 years will be included into the study. The data according to the protocol of the study will be assessed at the stage of inclusion, during the surgery, in 30 days after the surgery, and in 1, 2, and 3 years after the surgery. Data about all the patients included into the research will be analyzed in order to study the endpoints and achieve the research aim.

Eligibility Criteria

Inclusion Criteria: * Age from 29 days to 12 years * Patient's official caregivers have to sign the informed consent after they are thoroughly explained the meaning of the study, its protocol and timelines. * Patients with manifestations, with mean gradient at the aortic valve \>40 mmHg with normal left ventricular ejection fraction (LVEF), or patients with manifestations with the mean gradient \< 40 mmHg with decreased LVEF, or patients with manifestations with severe aortic insufficiency, or patients without manifestations, but with decreased LVEF with aortic insufficiency, or patients with concomitant moderate aortic insufficiency and moderate aortic stenosis with manifestations. * Aortic Z-score over -1,5 * Absence of subvalvular and supravalvular aortic stenosis * Absence of intracardiac malformations requiring correction, except for septal defects Non-inclusion criteria: * Known hypersensitivity to aspirin, heparin, nitinol, intravenous contrast or contradictions to their administration due to other causes. * Previous replacement of the aortic valve with mechanical or xenografts. * Confirmed active sepsis or endocarditis. * Hypoplasia of the fibrous ring of the aortic valve with Z score under -1,5. * Life expectancy less than 3 years due to concomitant diseases. * Participation in another clinical research. * Indications for urgent surgery. * Intracardiac malformations requiring momentary surgical correction. * Geographical instability of a patient and his/her official caregivers, complicating significantly the constant contact during the study Exclusion Criteria: • Refusal of patient's caregivers to participate further in the study.

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